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Spotlight on CDER Science Explores Prescriber Perceptions of Boxed Warnings: A Qualitative Study

In this Spotlight on CDER Science, CDER and outside researchers conducted a qualitative study to explore how health care providers (HCPs) consider a boxed warning (BW) when they are making treatment decisions for their patients, and how HCPs communicate with patients about BW information. An important part of CDER’s work is communicating the most up-to-date safety information for medicines to help ensure that HCPs and their patients can make the most informed treatment decisions. One way that CDER does this is by including a BW in labeling for certain prescription medicines to highlight important information for HCPs about serious risks associated with the medicine. While BWs are an important risk management tool, little is known about their intended – and potentially unintended—impacts on HCP prescribing or patients’ use of medicines that have a BW. Interviews with HCPs in this study revealed that a BW in labeling for a prescription medicine is only one of several factors that can influence providers’ treatment decisions, and that the potential influence of the BW depends on the context. Findings from this study underscore the nuanced complexity and context-specific nature of individual patient benefit–risk decisions.

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